article thumbnail

Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 105
article thumbnail

The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

Tamper‑evident packaging is also recommended to prevent adulteration or contamination of the excipient. USP-NF Propylene Glycol Monograph: USP43-NF38, 2010, 3753. 5 Both compounds are limited to ≤0.1 percent or 1,000 ppm. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Ann Intern Med. 24 June 2008.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al.

article thumbnail

Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Advair lost US patent protection in 2010 and exclusivity on the Diskus inhaler went in 2016 – but it took until February 2019 for the FDA to approve a generic from Mylan, now part of Viatris. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

article thumbnail

Breaking through the forecasting fog – 3 trends that will impact critical medicine supply in 2023

pharmaphorum

The same goes for many commodities used in the production process for key medicines, from solvents through to packaging. He previously held regional leadership roles at Sandoz between 2005 and 2010. These are driven by an unusually high level of respiratory infections following the end of pandemic-related social distancing measures.

Packaging 105
article thumbnail

Digital investment promises to accelerate the use of wearable sensor data in clinical trials

pharmaphorum

Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We In 2010, when we founded VivoSense, we developed a software platform for analysis of wearable sensor data and electronic patient-recorded outcomes (PRO) and patient diary information.

article thumbnail

Shining a light on Raman for microbiological analysis

European Pharmaceutical Review

With Raman spectroscopy, the scattering efficiency is low, which means that the search for, and attempts to interpret, subtle spectral differences can sometimes be problematic, especially where there is background noise caused from other materials (either in the sample or from packaging) and because bacteria produce a relatively weak signal.

Labelling 121